Xper Information Management System 98960612834x

GUDID 00884838098985

The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic, hemodynamic, clinical, medical image and other related data. The system is capable of processing / analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a standalone device.

Philips Medical Systems Nederland B.V.

Patient health record information system

• Primary Device ID: 00884838098985
• NIH Device Record Key: e2ca3a6f-1b0a-4bc1-8eb6-fa78441fda69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xper Information Management System
• Version Model Number: 2.6
• Catalog Number: 98960612834x
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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• Phone: +1(999)999-9999
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838098985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101571

FDA Product Code

• DQK: Computer, diagnostic, programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-15
• Device Publish Date: 2020-01-07

On-Brand Devices [Xper Information Management System]

• 00884838087330: The Xper Information Management System is used for acquiring, displaying, trending, storing and
• 00884838085213: The information management system is intended for use under the direct supervision of a healthca
• 00884838081291: 2.2
• 00884838070721: 2.1
• 00884838070691: 1.5
• 00884838091771: The Xper Information Management System is used for acquiring, displaying, trending, storing and
• 00884838098985: The information management system is intended for use under the direct supervision of a healthca
• 00884838100084: The Xper Information Management System is used for acquiring, displaying, trending, storing and
• 00884838105034: The Information Management System is a software to acquire, display, trend, store, and transmit